Kanomax Model 6113 Intelligent Thermal Anemometer for Pharmaceutical Cleanroom Air Velocity and Temperature Monitoring

Overview

The Kanomax Model 6113 Intelligent Thermal Anemometer is a precision-engineered, handheld environmental monitoring instrument specifically designed for validation, qualification, and routine operational monitoring in regulated pharmaceutical cleanrooms and controlled environments. It operates on constant-temperature anemometry (CTA) principles—measuring convective heat transfer from a heated sensor element to the surrounding airflow—to deliver stable, low-drift velocity measurements across a wide dynamic range (0.1–50.0 m/s). Its integrated thermistor-based temperature sensor and differential pressure transducer enable simultaneous acquisition of air velocity, ambient temperature, and static pressure—three critical parameters required for ISO 14644-3 cleanroom certification, EU GMP Annex 1 airflow uniformity assessments, and HVAC system commissioning per ASHRAE Standard 110. The instrument’s robust mechanical architecture, IP54-rated enclosure, and modular probe design ensure reliable performance in ducts, laminar flow hoods, and ISO Class 5–8 cleanroom zones where particulate control and airflow integrity are subject to FDA 21 CFR Part 211 and ICH Q9 requirements.

Key Features

• Triple-parameter synchronous measurement: real-time acquisition of air velocity, temperature (0–100 °C), and differential pressure (−5 to +5 kPa) with traceable calibration paths.
• Modular, interchangeable probe design—field-replaceable sensing heads minimize downtime during maintenance or probe damage without requiring full unit recalibration.
• Large backlit LCD display with intuitive single-button operation for data logging, statistical calculation (min/max/average), and on-site thermal printing—eliminating post-test manual transcription errors.
• Built-in non-volatile memory stores up to 100 complete test records, each timestamped and tagged with user-defined location identifiers for audit-ready documentation.
• Standard RS-232C serial interface supports direct connection to PCs or LIMS systems; optional 0–1 V analog output enables integration into building management systems (BMS) or PLC-controlled monitoring networks.
• Compact, ergonomic housing (210 × 120 × 133 mm) with 1.0 kg mass ensures portability across multi-point cleanroom mapping campaigns while maintaining mechanical stability during handheld use.

Sample Compatibility & Compliance

The Model 6113 is validated for use in non-corrosive, particle-laden airstreams typical of HEPA-filtered cleanroom supply ducts, return grilles, and unidirectional airflow (UDAF) workstations. Its stainless-steel probe tip resists contamination buildup and complies with ISO 14644-1 surface cleanliness requirements when cleaned using isopropyl alcohol (IPA)-based protocols. All measurement functions adhere to ASTM D5465–22 (Standard Test Method for Air Velocity Measurements in Cleanrooms) and support compliance with ISO 14644-3 Annex B (Airflow Uniformity Testing), EU GMP Annex 1 §4.37–4.42 (Airflow Visualization and Velocity Mapping), and USP <1116> Environmental Monitoring for Aseptic Processing. Calibration certificates include NIST-traceable reference data and uncertainty budgets aligned with ISO/IEC 17025:2017.

Software & Data Management

Data export is facilitated via ASCII-formatted RS-232C transmission, compatible with standard spreadsheet applications and validated laboratory informatics platforms. Each stored record includes raw values, calculated statistics, date/time stamps, and operator ID fields—enabling full traceability per FDA 21 CFR Part 11 electronic record requirements when paired with appropriate access controls and audit trail software. Optional Kanomax PC software provides batch export, trend charting, and deviation flagging against pre-set acceptance limits (e.g., ≥0.45 m/s ±20% for Grade A zones). No cloud connectivity or proprietary drivers are required—ensuring compatibility with air-gapped GxP IT environments.

Applications

• ISO Class 5–8 cleanroom airflow velocity mapping and uniformity verification per ISO 14644-3.
• HEPA filter leak testing support by quantifying upstream/downstream face velocities.
• HVAC system commissioning, balancing, and requalification after facility modifications.
• Environmental monitoring program execution in sterile manufacturing suites and isolator glove ports.
• Validation of laminar airflow cabinets (LFAs), biosafety cabinets (BSCs), and RABS systems per NSF/ANSI 49 and EN 12469.
• Thermal profiling of drying ovens and lyophilizer chambers where air movement affects product moisture removal kinetics.

FAQ

Is the Model 6113 suitable for ISO 14644-3 cleanroom certification audits?

Yes—it meets the metrological and procedural requirements for velocity measurement uncertainty, sampling density, and documentation specified in ISO 14644-3 Annex B.
Can the instrument be calibrated in-house using traceable standards?

Field calibration requires certified reference anemometers and environmental chambers; full recalibration must be performed by Kanomax-authorized service centers or ISO/IEC 17025-accredited labs.
Does the built-in printer support regulatory-compliant record retention?

Thermal printouts include all required metadata (time stamp, location ID, operator, units); however, digital storage with audit trail is recommended for long-term GxP compliance.
What is the typical battery life under continuous operation?

Approximately 12 hours using alkaline AA cells at 25 °C ambient; battery status is continuously monitored and displayed.
Are replacement probes available with different lengths or geometries?

Yes—Kanomax offers straight, bent, and telescopic probe variants (e.g., 6113-P1, 6113-P2) optimized for duct, grille, and hood access constraints.